FDA Begins Intercenter Pilot Project on Combination Products

The US Food and Drug Administration (FDA) announced Monday that it is beginning a new pilot project linked to its intercenter consult request (ICCR) process for combination products of drugs, medical devices and/or biologics.

To improve combo product submission review at FDA, the agency is stressing the need for closer intercenter collaboration and communication and is planning to test certain aspects of those collaborations in the pilot, with the goal of achieving implementation across all FDA offices by the end of Q2 2017.

Background

In 2014, after an industry survey highlighted concerns over communication and coordination issues during intercenter consults for combination products, FDA's Office of Planning (OPL) launched a study into how to improve the coordination and communication around combination products.

Specifically, the study aimed to look into "management, timing, timeliness, and workload challenges" related to intercenter consults. FDA staff also sought input from two industry groups, the Combination Products Coalition (CPC) and the Advanced Medical Technology Association (AdvaMed), on issues industry faces from such intercenter consults.

After receiving input, the study team held a series of focus groups with staff from the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER) and conducted 18 interviews with FDA staff to identify four main issues: different policies, practices and application types; separate review and tracking systems between centers; unclear communication channels between centers; and a lack of resources to review consults.

The study team then issued five recommendations, which FDA Commissioner Robert Califf endorsed, for the agency to improve combo product reviews:

• "Establish clear guidance for the review of common combination product types."
• “Create new simplified processes for access to CDER’s Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) and CDRH’s Image 2000 for consulting reviewers."
• "Update the Intercenter Consultative/Collaborative Review Process Standard Operating Procedures and Policies (SOPP) Manual and Intercenter Consult Request form and make them easily accessible on the OCP website."
• "Create and maintain a combination-product-specific organizational chart and contact directory, keeping personnel changes current."
• "Establish a mechanism for estimating time spent on intercenter consults so resources can be allocated appropriately to organizational units to assure adequate review performance."

The recommendations came as FDA continues to delay the finalization of a rulemaking on the postmarket safety reporting for combination products, which was first proposed in 2009 and slated for final release in May, but has yet to materialize.

Pilot Project

Michael Rappel, a senior science advisor in CDER, and Rachel Sherman, FDA’s associate deputy commissioner for medical products and tobacco, wrote in a blog post on Monday that FDA will conduct its intercenter pilot in three phases, the first and second of which will be used to help refine the initial steps of the ICCR process (e.g., consult request, ICCR form, reviewer assignment) though they say that “some limited consult completion data (e.g., consult quality and timeliness) available for Investigational Device Exemptions/Investigational New Drugs may provide initial insights on consult closeout.”

The pilot will aim to address four improvements targeted at the review team's recommendations:

• establishing timelines, specific to center and submission type, for identifying combo products and issuing and completing consults needed to support each review
• developing a “tiered consult approach” that expedites interactions across FDA centers and identifies a clearer process for identifying the right experts for a consult
• defining clear roles and responsibilities for the “Lead Center, the Consulted Center(s), the Office of Combination Products (OCP), and the Combination Product Council” for review of a combo product submission
• creating a standard, semi-automated, user-friendly ICCR form that is managed electronically to ensure 1) users always have the most updated version, and 2) all forms, and thus all intercenter combination product consults, are tracked through a single system

“During each phase of implementation, we will collect quantitative and qualitative data to evaluate success,” Rappel and Sherman write. “What we learn at each stage will allow us to refine processes, procedures, and training for subsequent phases. In particular, data from phases 1 and 2 consult completion data for other submission types will also be collected but may not be available for several months due to the longer submission review timelines.”

For those with feedback or input on the pilot, Rapel and Sherman are available at: combinationproductICCRpilot@fda.hhs.gov.